(336 days)
The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
The Disposable Medical Masks are non-sterile, single use, 3 layers, flat-pleated style surgical masks. Each mask contains ear loops made of nylon and spandex to secure the mask over the user's face and mouth with nose piece made of polypropylene to firmly fit over the nose. The size of the mask body is 14 cm×9 cm and the dimension of the ear loop is 8 cm × 0.3 cm, the dimension of nose piece is 9.4 cm×0.3 cm. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene. Color of the inner facing layer of the mask is white and color of the outer facing layer is blue. The middle layer consists of white Melt Blown Polypropylene Filter.
50 masks are packed in a polyethylene plastic bag and placed in the package box made of white cardboard. Outside the package box there is also a PE plastic film cover on the box. This device is not made from any natural rubber latex.
The document describes the acceptance criteria and performance of the Disposable Medical Mask (Model: RYSM001) manufactured by Yangzhou Runyi Arts & Crafts CO., LTD. It is a 510(k) summary demonstrating substantial equivalence to a predicate device (Single-use Medical Face Mask, K203591 from Conod Medical Co., Limited).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Resistance (ASTM F1862) | Level 2: 29 out of 32 passed at 120 mmHg (AQL 4%) | Pass (32 out of 32 passed at 120 mmHg, Level 2 Fluid Resistance) in non-clinical testing, and stated as "Pass" in the summary table. |
| Particulate Filtration Efficiency at 0.1 micron (ASTM F2299) | Level 2: ≥ 98% (AQL 4%) | Pass (≥99% as per comparison table, and stated as "Pass" in the summary table). Also, average 99.80% reported for the predicate device, with similarity claimed for the proposed device. |
| Bacterial Filtration Efficiency (ASTM F2101-19) | Level 2: ≥ 98% (AQL 4%) | Pass (≥99% as per comparison table, and stated as "Pass" in the summary table). Also, average 99.77% reported for the predicate device, with similarity claimed for the proposed device. |
| Differential Pressure (Delta P) (MIL-M-36954C) | Level 2: < 6.0 mmH2O/cm² (AQL 4%) | Pass (Average 4.01 mmH2O/cm² as per comparison table, and stated as "Pass" in the summary table). |
| Flammability (16 CFR 1610) | Class 1 (Non-Flammable) (AQL 4%) | Pass (Class 1) |
| Cytotoxicity (ISO 10993-5) | Non-Cytotoxic | Pass (Non-Cytotoxic) |
| Skin Sensitization Test (ISO 10993-10) | Non-Sensitizing | Pass (Non-Sensitizing) |
| Skin Irritation Test (ISO 10993-10) | Non-Irritating | Pass (Non-Irritating) |
2. Sample Size Used for the Test Set and the Data Provenance
- For the performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flame Spread):
- Sample Size: 3 non-consecutive lots, with 32 samples per lot.
- Data Provenance: The tests were conducted internally by the manufacturer or a contracted testing facility as part of the premarket notification (K203112) for the proposed device (Disposable Medical Mask, RYSM001). The data comes from non-clinical bench testing. The country of origin for the data is implicitly China, given the manufacturer's address. It is retrospective data collected for submission.
- For Biocompatibility tests (Cytotoxicity, Sensitization, Irritation):
- The document implies that these tests were conducted on the proposed device to meet the ISO 10993 standards, indicating testing of the device materials. Specific sample sizes for these tests are not provided in the summary but are generally conducted on material extracts or actual device materials according to the standard.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This document describes non-clinical, bench-top performance and biocompatibility testing of a medical mask. It does not involve human expert adjudication or ground truth establishment in the way this question typically refers to it (e.g., for AI/image analysis studies). The "ground truth" for these tests are the established standards and their predefined pass/fail criteria, as determined by the scientific community and regulatory bodies. Therefore, no human experts were used to establish ground truth for this device in the context of the provided document.
4. Adjudication Method for the Test Set
Not applicable. As this is non-clinical bench testing against established performance standards, there is no human adjudication or consensus method like 2+1 or 3+1. The results are quantitative measurements compared against predefined thresholds.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No. This document pertains to the 510(k) submission for a physical medical device (mask) based on non-clinical performance and biocompatibility testing. It specifically states "No clinical study is included in this submission." Therefore, an MRMC comparative effectiveness study was not conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used
The ground truth used for performance validation is based on established international and national standards for medical face masks and biocompatibility:
- Performance Standards: ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36945C, 16 CFR 1610. These standards define the test methodologies and the acceptance criteria (e.g., minimum filtration efficiency, maximum differential pressure, specified fluid resistance).
- Biocompatibility Standards: ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Irritation). These standards provide protocols for evaluating the biological response to medical devices and define acceptable limits for these biological effects.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set. The device is a physical product validated through bench testing.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth to be established for it.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 16, 2021
Yangzhou Runyi Arts & Crafts CO., LTD. % Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room302, Building3, Hangqian Mansion, Hangqian Street, Lucheng District Wenzhou, Zhejiang 32500 China
Re: K203112
Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 13, 2021 Received: September 13, 2021
Dear Helen Nan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Liqun Zhao -S
For Clarence W. Murray III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203112
Device Name Disposable Medical Mask
Indications for Use (Describe)
The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 201 Subpart D)Over-The-Counter Use (21 CFR 201 Subpart C) | Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
|_ | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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YANGZHOU RUNYI ARTS & CRAFTS CO., LTD.
K203112 510(k) Summary (As required by 21 CFR 807.92)
1.0 Submitter Information
| Company: | YANGZHOU RUNYI ARTS & CRAFTS CO., LTD. |
|---|---|
| Address: | 4.NO.87 West Heye Road HanJiang DistrictYangzhou,Jiangsu,225008,CHINA |
| Phone: | 086-514-82082789 |
| Contact Person: | Li Yu |
| Title: | Legal Person |
| E-mail: | yzsunnytoys@aliyun.com |
| • Date of Preparation: September 15, 2021 |
2.0 Device Information
| Trade/Device Name: | Disposable Medical Mask |
|---|---|
| Model: | RYSM001 |
| Regulation Description: | Surgical apparel |
| Device: | Mask, Surgical |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Device Class: | Class II |
3.0 Predicate Device Information
| Trade/Device Name: | Single-use Medical Face Mask |
|---|---|
| 510k Number: | K203591 |
| Submitter: | Conod Medical Co., Limited |
4.0 Device Description
The Disposable Medical Masks are non-sterile, single use, 3 layers, flat-pleated style surgical masks. Each mask contains ear loops made of nylon and spandex to secure the mask over the user's face and mouth with nose piece made of polypropylene to firmly fit over the nose. The size of the mask body is 14 cm×9 cm and the dimension of the ear loop is 8 cm × 0.3 cm, the dimension of nose piece is 9.4 cm×0.3 cm. The outer layer and inner facing layer of face mask consists of Spunbond Polypropylene. Color of the inner facing layer of the mask is white and color of the outer facing layer is blue. The middle layer consists of white Melt Blown Polypropylene Filter.
50 masks are packed in a polyethylene plastic bag and placed in the package box made of white cardboard. Outside the package box there is also a PE plastic film cover on the box. This device is not made from any natural rubber latex.
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YANGZHOU RUNYI ARTS & CRAFTS CO., LTD.
5.0 Indications for Use
The Disposable Medical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile.
| Device | Predicate Device | Proposed Device | Comparison |
|---|---|---|---|
| Manufacturer | Conod Medical Co.,Limited | YANGZHOU RUNYIARTS & CRAFTSCO., LTD. | N/A |
| 510K Number | K203591 | K203112 | N/A |
| Trade/DeviceName | Single-use MedicalFace Mask | Disposable MedicalMask | N/A |
| Product Code | FXX | FXX | Same |
| Classification | Class II(21 CFR 878.4040) | Class II(21 CFR 878.4040) | Same |
| Indicationsfor Use | The Single-useMedical Face Masksare intended to beworn to protect boththe patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device(s),provided non-sterile. | The DisposableMedical Masks areintended to be worn toprotect both the patientandhealthcarepersonnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device(s),provided non-sterile. | Same |
| Material | |||
| Outer FacingLayer | SpunbondPolypropylene | SpunbondPolypropylene | Same |
| Middle Layer | Melt Blown | Melt Blown | Same |
| YANGZHOU RUNYU ARTS & CRAFTS CO., LTD. | |||
| PolypropyleneFilter | PolypropyleneFilter | ||
| Inner FacingLayer | SpunbondPolypropylene | SpunbondPolypropylene | Same |
| Nose Piece | Malleable aluminumwire | Polyethylene | Different |
| Mask Style | Flat pleated | Flat pleated | Same |
| Design feature | Earloop, Tie Coverall,3 layers | Earloop, 3 layers | Same |
| Ear loops/Ties | Ear loops: PolyesterTie tapes: Spun-bondPolypropylene | Ear loops: Spandexand nylon | Different |
| Color | Blue | Blue | Same |
| Dimension(Length ×Width) | Earloop:17.5 cm × 9.5 cm16.5 cm × 9.0 cm14.5 cm × 9.5 cmTie Coverall:17.5 cm × 9.5 cm | Earloop:14 cm × 9 cm | Similar |
| OTC Use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| ASTM F2100Level | Level 2 | Level 2 | Same |
| Non-Clinical Performance Testing | |||
| FluidResistancePerformanceASTM F1862 | 32 Out of 32 pass at120 mmHg(Level 2 FluidResistance) | 32 Out of 32 pass at120 mmHg(Level 2 FluidResistance) | Same |
| ParticulateFiltrationEfficiencyASTMF2299 | Average 99.80% | ≥99% | Similar |
| BacterialFiltrationEfficiency | Average 99.77% | ≥99% | Similar |
6.0 Summary of Comparison and Technological Characteristics
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YANGZHOU RUNYI ARTS & CRAFTS CO., LTD.
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| YANGZHOU RUNYI ARTS & CRAFTS CO., LTD. | |||||||
|---|---|---|---|---|---|---|---|
| ---------------------------------------- | -- | -- | -- | -- | -- | -- | -- |
| ASTMF2101 | |||
|---|---|---|---|
| DifferentialPressure(Delta P)MIL-M-36954C | Average$4.01 \text{ mmH2O/cm}^2$ | $< 6.0 \text{ mmH2O/cm}^2$ | Similar |
| Flammability16 CFR 1610 | Class 1 | Class 1 | Same |
| Biocompatibility | |||
| CytotoxicityISO 10993-5 | Non-Cytotoxic | Non-Cytotoxic | Same |
| SensitizationISO 10993-10 | Non- Sensitizing | Non- Sensitizing | Same |
| IrritationISO 10993- | Non-Irritating | Non-Irritating | Same |
Discussion:
First, the subject device shares the same intended use with the predicate device.
Secondly, the subject device enjoys similar technological characteristics with the predicate device. For example, they enjoy the same fluid resistance level, they are both for OTC use. Although there are differences in physical specifications such as the smaller mask dimensions, it's still similar. Therefore such differences will not affect the core usage of the subject device as a single use surgical mask and the usage effectiveness of the subject device has been verified by the performance tests listed in the comparison table.
Thirdly, the subject device enjoys same mask body materials, but the nose piece and earloop materials are different with the predicate device, the material safety of the subject device have been evaluated by relevant ISO 10993 standards, which further proves that the subject device will be as safe for use as the predicate device.
7.0 Non-Clinical Performance Testing
The following performance data demonstrated in 3 non-consecutive lots were provided demonstrate that the subject device met the specification found in the standard. The results demonstrated that the subject device meets the acceptance criteria found in the standard.
7.1 Conformity to Standards
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YANGZHOU RUNYI ARTS & CRAFTS CO., LTD.
| Standards | Name |
|---|---|
| ASTMF1862/F1862M-17 | Standard Test Method for Resistance of Medical FaceMasks to Penetration by Synthetic Blood (HorizontalProjection of Fixed Volume at a Known Velocity) |
| ASTM F2100-19 | Standard Specification for Performance of Materials Usedin Medical Face Masks |
| ASTM F2101-19 | Standard Test Method for Evaluating the BacterialFiltration Efficiency (BFE) of Medical Face MaskMaterials Using a Biological Aerosol of Staphylococcusaureus |
| MIL-M-36945C | Differential Pressure (Delta-P) |
| ASTMF2299/F2299M-03 | Standard Test Method for Determining the InitialEfficiency of Materials Used in Medical Face Masks toPenetration by Particulates Using Latex Spheres |
| 16 CFR PART1610 | Standard for the flammability of clothing textiles |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests forin vitro cytotoxicity |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Testsfor Irritation and skin sensitization |
7.2 Performance Testing-Bench
| Standards | Test purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Resistance topenetration bysynthetic bloodASTM F1862 | Testing the efficiencyof resistance topenetration bysynthetic blood. | Level 2: 29 out of 32passed in 120 mmHg3 non-consecutivelots, 32 samplesper lot, AQL 4% | Pass |
| Sub-micronparticulate filtrationefficiency at0.1 micronASTM F2299 | Testing the efficiencyof the filter material incapturing aerosolizedparticles smaller thanone micron. | Level 2: ≥ 98%3 non-consecutivelots, 32 samplesper lot, AQL 4% | Pass |
| Bacterial filtrationefficiencyASTM F2101-19 | Testing theeffectiveness ofmedical face maskmaterial in preventing | Level 2: ≥ 98%3 non-consecutivelots, 32 samples | Pass |
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| the passage ofaerosolized bacteria. | per lot, AQL 4% | ||
|---|---|---|---|
| Differentialpressure MIL-M-36954 | Measuring thepressure of droppingacross a medical facemask material. | Level 2:< 6.0mmH2O/cm²3 non-consecutivelots, 32 samplesper lot, AQL 4% | Pass |
| Flame spread16 CFR 1610 | Testing thecharacteristics of amaterial that pertainto its relative ease ofignition and relativeability to sustain combustion. | Class 1Non-Flammable3 non-consecutivelots, 32 samplesper lot, AQL 4% | Pass |
YANGZHOU RUNYI ARTS & CRAFTS CO., LTD.
7.3 Biocompatibility Testing
| Standards | Proposed Device | Result |
|---|---|---|
| CytotoxicityISO 10993-5 | Under the conditions of the study, thedevice is non-cytotoxic. | Pass |
| Skin Sensitization TestISO 10993-10 | Under the conditions of the study, thedevice is non-sensitizing. | Pass |
| Skin Irritation TestISO 10993-10 | Under the conditions of the study, thedevice is non-irritating. | Pass |
8.0 Clinical Performance Testing
No clinical study is included in this submission.
9.0 Conclusion
The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 878.4040 Surgical apparel.
(a)
Identification. Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.(b)
Classification. (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible.
(ii) Analysis and nonclinical testing must:
(A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and
(B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device.
(iii) NIOSH approved under its regulation.
(2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.